New technology for detecting asthma through exhaled nitric oxide

The Diagnostic Significance of Exhaled Nitric Oxide (FeNO) With a Novel Technology in the Assessment of Bronchial Asthma

This study is testing a new way to diagnose asthma by measuring levels of nitric oxide in the breath to see if it can help both asthma patients and healthy people.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Novlead Inc. (industry)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT06852911 on ClinicalTrials.gov

What this trial studies

This study evaluates a novel approach for diagnosing bronchial asthma by measuring exhaled nitric oxide (FeNO) levels, which are indicative of airway inflammation. Participants, including both asthmatic patients and healthy individuals, undergo a series of pre-testing requirements to ensure accurate results. The FeNO test is performed using advanced analyzers that utilize chemiluminescence and electrochemical methods. The goal is to improve the diagnostic process for asthma and related airway diseases through non-invasive testing.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of bronchial asthma and respiratory symptoms lasting at least six weeks.

Not a fit: Patients currently using asthma medications or those with recent respiratory infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate and timely diagnoses of asthma, improving patient management and outcomes.

How similar studies have performed: Previous studies have shown promise in using FeNO as a biomarker for asthma diagnosis, indicating that this approach is supported by existing research.

Eligibility criteria

Patients:

Inclusion Criteria:

1. Participants must be a minimum of 18 years of age, irrespective of gender;
2. Individuals must possess a diagnosis of bronchial asthma that aligns with the international GINA 2023 diagnostic criteria;
3. Respiratory symptoms must have been evident for at least 6 weeks;
4. Participants should either have no history of smoking or have discontinued smoking for a period exceeding 5 years.

Exclusion Criteria:

1. The concurrent use of additional asthma medications (such as glucocorticoids) alongside short-acting bronchodilators within the prior 4 weeks;
2. A diagnosis of respiratory infection within the preceding 4 weeks;
3. Conditions such as pregnancy, lactation, or menstruation;
4. Participation in other clinical research studies;
5. Any underlying medical or psychiatric conditions that, in the investigator's assessment, would render the individual unsuitable for participation in the study.

Healthy:

Inclusion Criteria:

1. Participants must be at least 18 years of age, with no restrictions on gender;
2. Individuals should not have a history of allergic diseases or chronic respiratory conditions, and must not exhibit any significant abnormalities in health assessments conducted within the past year;
3. There should be no acute illnesses or medication history within the preceding four weeks, and participants must not display any typical symptoms of respiratory infections;
4. A history of smoking is not permitted, or individuals must have ceased smoking for a minimum of five years.

Exclusion Criteria:

1. Individuals who are pregnant, breastfeeding, or currently experiencing menstruation;
2. Those who have been on long-term medication;
3. Participants involved in other clinical research studies;
4. Any potential medical or psychological conditions that the researcher deems may render the subject unsuitable for participation in the study.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Ruijin Hospital — Shanghai, Shanghai Municipality, China (COMPLETED)
• Wuxi Xinwu District Xinrui Hospital — Wuxi, China (RECRUITING)

Study contacts

• Principal investigator: Ailing Song — Wuxi Branch of Ruijin Hospital (Xinrui Hospital of Xinwu Distric, Wuxi)
• Study coordinator: Zhou Fang

Conditions: Bronchial Asthma, Airway Disease, FeNO, Bronchial asthma, Tidal breathing